MAP BioPharma

As previously reported, in mid-October the German Federal Government presented a bill concerning changes to the market access and pricing legislation for pharmaceuticals (Gesetz zur Stärkung der Arzneimittelversorgung in der GKV). There will be a first reading of the bill on 25 November, followed by further readings in both chambers of the German Parliament. At the time being, it is envisaged that the new law shall enter into force on 1 April 2017.

Please find in the following the most important provisions as suggested by the government. Please bear in mind that they can be amended in the course of the legislative procedure:

Extension of the price moratorium until the end of 2022: The prices for pharmaceuticals will be kept at the level of 2009, i.e. manufacturers are barred from increasing their prices for another five years. Although the bill provides for a compensation for inflation, even if this provision finds its way into the adopted text it cannot balance the losses incurred since the introduction of the price freeze in 2010 (cf. Article 1, No. 9 of the bill).

Principle of free pricing in the first year only kept up to a revenue threshold of EUR 250 million: If this threshold is exceeded within the first twelve months, the price negotiated between the manufacturer and the National Association of Statutory Health Insurance Funds will apply retrospectively as of the first month following the month in which the threshold was exceeded. The suggested threshold would most likely only affect a small number of products but there is still the possibility that the threshold will be lowered in the course of the parliamentary debates (cf. Article 1, No. 10 e).

Joint Federal Committee (GBA) entitled to initiate a benefit assessment for medicinal products with a known active substance: This shall be possible if an already marketed product is authorised for a new indication which triggers a new ten years period of data exclusivity or if the data exclusivity period is still running for the medicinal product firstly authorised with this active substance. Since the wording in the bill leaves the decision to initiate the process with the GBA, it will cause of lot of legal uncertainty despite the fact that the government had confirmed in the past that they would not introduce a general benefit assessment for known substances (cf. Article 1, No 3d).

The reimbursed price negotiated between companies and the payers shall not be published: Originally, this provision was widely welcomed since the draft provides that “only public bodies that require this information to fulfil their legal obligations” shall be entitled to access these otherwise confidential information. In recent discussions, however, concerns were expressed that due to the fact that the law lacks a definition what these legal obligations could be, in the end also the negotiated prices would be known to a wide range of stakeholders. It would be vital to include a sound confidentiality clause into the law in order to have an effective protection of confidential prices. Altogether, it might be that the provision as it is currently phrased will not improve the status quo(cf. Article 1, No. 10b).

The current version of the bill does not suggest any changes concerning the rule that for orphan medicinal products with a yearly turnover of less than EUR 50 million the additional benefit (usually subject to an early benefit assessment by the G-BA) is considered to be already proven through the grant of the marketing authorisation. Given the continuous discussions about the prices of OMPs at Member States’ and EU level, this is an important sign. However, as mentioned above, there is at least a chance that changes to this established rule and other aspects of the bill will be introduced during the legislative procedure.